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Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons

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ClinicalTrials.gov Identifier: NCT04401449
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief Summary:

Background:

COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it.

Objective:

To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection.

Eligibility:

People ages 18-80 with COVID-19 infection

Design:

Participants will be screened with a review of their medical records.

Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests.

Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein.

Participants will have an ultrasound of the kidneys and heart.

Participants will provide blood and urine samples. They will provide nasal swabs.

Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction.

Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid.

Participants will have lung and heart function tests.

At various points after recovery, participants will repeat many of these tests.


Condition or disease
Acute and Long Term Effects of COVID-19:on Systemic Inflammation Acute and Long Term Effects of COVID-19 on Lung Function Acute and Long Term Effects of COVID-19 on Mrain Function Acute and Long Term Effects of COVID-19 on Cardiac Function Acute and Long Term Effects of COVID-19 on Kidney Function

Detailed Description:

There is little sequential, methodically collected data on patients with COVID-19 that can be correlated with the severity of disease or the long-term sequelae. Such information is necessary to understand how to most logically intervene with directly acting antiviral agents and immunologic response modifiers. The variability of the clinical course of patients who may be asymptomatic throughout their clinical course to those patients who develop progressive multisystem organ failure represents a challenge to understand the host and viral factors that result in these dramatically different outcomes.

This protocol will enroll patients to the Clinical Center in a longitudinal study using granular clinical, laboratory, and imaging data including extensive pulmonary and cardiac functional assessments, neurologic evaluation, comprehensive immunologic evaluations, and innovative imaging. In patients with COVID-19 infection, linking sequential analysis of blood, urine and bronchoalveolar lavage with simultaneous cardiopulmonary imaging can provide novel insights into mechanisms associated with the initiation, progression and resolution of lung, cardiac and systemic inflammation. These mechanisms are presumed to be essential in the pathogenesis and survival from this infection. This information will help guide diagnostic and therapeutic innovation and assess long-term consequences of this infection.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons (COVID ARC 19)
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Group/Cohort
Acutely illl subjects
COVID-19 subjects treated at the Clinical Center, followed through recovery and intoconvalescence
Recovered subjects
COVID-109 subjects who were treated at other hospitals, followed through recovery and into convalescence



Primary Outcome Measures :
  1. Inflammatory responses of cells in lung and circulation [ Time Frame: From onset of illness in hospital through acute phase ( days 1 28 more or less 7), at the time of resolution of infection ( day 28 more or less 7 to 6 weeks, andduring convalescence (6 months to 1 year after the infection) ]
    Link inflammatory responses present in blood, urine and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain and kidneys) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects 18-80 years old, male or female will be enrolled within 14 - 28 days of documented COVID-19 infection for acute care OR during recovery and convalescent phase of the acute illness (day 28 and beyond) if care has been received at a facility outside of NIH. Subject will be from the MDV medtropolitan area.
Criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Subjects within 1-28 days of documented COVID-19 infection for acute care:

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 to 80 years

    • Only a minority of children and adolescents have been described as developing serious illness with COVID-19 infection. As such, this is not an age group at significant risk from complications due to this infection. Adults older than 80 years of age represent a group with the greatest risk of mortality from COVID-19 infection. The presence of significant co-morbidities requiring care that cannot be

provided at the CC would present a disadvantage to them to have their acute care provided for in the CC.

  • Documentation of positive SARSCoV-19 test by nucleic acid detection (COVID-19 infection , RT-PCR)
  • Ability of subject to understand and the willingness to sign a written informed consent document.

Subjects during recovery phase of the acute illness (day 28 and beyond) if care has been received at a facility outside of NIH:

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 to 80 years

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Pregnancy or lactation
  • Serious mental illness (e.g. schizophrenia, manic depression) that would limit the ability of the participant to participate willingly into the study.

    --The conduct of the study requires participation in studies that may be unduly stressful (e.g. MRI, bronchoscopy).

  • Severe claustrophobia that would prohibit the conduct of imaging by MRI even if sedation is provided.
  • Patients requiring mechanical ventilation at an outside hospital prior to transfer. Transporting these patients adds risk to their care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401449


Contacts
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Contact: Natural History COVID Study (COVID ARC 1 Not Listed nathx_covid@nih.gov

Locations
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United States, District of Columbia
MedStar Health Research Institute /MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Christopher Barnett, M.D.    202-877-3321      
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Anthony F Suffredini, M.D. National Institutes of Health Clinical Center (CC)
Additional Information:
Publications:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT04401449    
Other Study ID Numbers: 200113
20-CC-0113
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 19, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC):
Immunological Function
SARS-CoV-2
Neurologic Function
Cardiac Function
Pulmonary Function
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes